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Study of safety and efficacy of Venetoclax in combination with Vidaza (Azacitidine) in higher-risk Chronic Myelomonocytic Leukemia (CMML)
EU CTIS ID: 2024-514878-53-00
What this study is testing
To determine the safety of venetoclax + azacitidine in the study population during the run-in phase and the overall response rate in the phase II portion of the study
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age 18 and older
- CMML diagnosis according to ICC 2022 criteria
- Intermediate-2 or high risk according to the molecular CMML Prognostic Scoring System (CPSS-mol, Elena Blood 2016)
- No prior treatment with HMAs. Prior treatment with Erythropoiesis Stimulating Agents (ESA) is allowed with a > 15 days washout from ESAs. Prior treatment with hydroxurea (HY) is acceptable.
- ECOG Performance status 0-2
- Adequate organ function: total bilirubin < 2 times upper limit of normal (ULN), ALT and AST < 3 times ULN, creatinine clearance > 30 mL/min.
You likely can't join if
- Myeloproliferative / myelodysplastic syndrome other than CMML
- Malabsorption syndrome or other condition that precludes an enteral route of administration
- Previous therapy with a hypomethylating agent for CMML or any antecedent condition
- Previous therapy with a BH3 mimetic
- Antecedent allogeneic stem cell transplantation (HSCT) for CMML or an antecedent of hematological malignancy. Those never transplanted but eligible for HSCT are eligible for the trial.
- Subjects referred to in Articles L1121-5 to L1121-8-1 and L1122-1-2 of the Public Health Code
See the full eligibility criteria
- Age 18 and older
- CMML diagnosis according to ICC 2022 criteria
- Intermediate-2 or high risk according to the molecular CMML Prognostic Scoring System (CPSS-mol, Elena Blood 2016)
- No prior treatment with HMAs. Prior treatment with Erythropoiesis Stimulating Agents (ESA) is allowed with a > 15 days washout from ESAs. Prior treatment with hydroxurea (HY) is acceptable.
- ECOG Performance status 0-2
- Adequate organ function: total bilirubin < 2 times upper limit of normal (ULN), ALT and AST < 3 times ULN, creatinine clearance > 30 mL/min.
- Signed Informed Consent Form
- Negative pregnancy and adequate contraception (including in male patients) if relevant
- Affiliation to a health insurance system
- Myeloproliferative / myelodysplastic syndrome other than CMML
- Malabsorption syndrome or other condition that precludes an enteral route of administration
- Previous therapy with a hypomethylating agent for CMML or any antecedent condition
- Previous therapy with a BH3 mimetic
- Antecedent allogeneic stem cell transplantation (HSCT) for CMML or an antecedent of hematological malignancy. Those never transplanted but eligible for HSCT are eligible for the trial.
- Subjects referred to in Articles L1121-5 to L1121-8-1 and L1122-1-2 of the Public Health Code
- Bone marrow or peripheral blood blasts (including promonocytes) ≥ 20%
- CMML with t(5;12) or PDGFRß rearrangement that may be treated with imatinib
- Unavailable CPSS-mol at inclusion (WBC prior to HY used to compute CPSS-mol at inclusion in HY-exposed patients) or with a CPSS-mol low or intermediate-1 at study entry
- Pregnant or breastfeeding
- Serious concomitant systemic disorder, including auto-immune or auto-inflammatory disease requiring > 20 mg/d prednisone equivalent, active bacterial, fungal or viral infection that in the opinion of the investigator, would compromise the safety of the patient and/or his/her ability to complete the study.
- Medical condition requiring therapies with CYP3A strong or moderate inducing or inhibiting activity at screening
- Prior malignancy (except in situ cervix carcinoma, limited basal cell carcinoma, asymptomatic prostatic cancer not requiring treatment, or other tumors if not active during the last 2 years)
- Known positive test for human immunodeficiency virus (HIV)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.